A Phase 1, Single Dose, Open-label Study to Investigate the Pharmacokinetics and Safety of Iptacopan (LNP023) in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Matched Control Healthy Participants With Normal Hepatic Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters of iptacopan: Cmax The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass × volume-1)
研究概览
简要总结
This was an open-label, single dose parallel group study to evaluate the PK of iptacopan in participants with mild, moderate, and severe hepatic impairment compared to matched healthy control participants.
详细描述
The study comprised of a screening period up to 28 days, one Baseline evaluation on Day -1, a single dose administration of 200 mg of iptacopan followed by PK sampling to 240 hr, and an End-of-Study (EOS) visit (Day 11). All participants had a post study safety follow-up call conducted approximately 30 days after last administration of study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants eligible for inclusion in this study met the following key criteria:
- •Written informed consent was obtained before performing any assessment.
- •Male participants and female participants of non-childbearing potential 18 to 75 years of age (inclusive).
- •Participants were to weigh at least 55 kg to participate in the study and were to have a body mass index (BMI) within the range of 18 to 35 kg/m2 for healthy participants.
- •For hepatic impairment participants without overt ascites, the BMI was to be within the range of 18 to 40 kg/m
- •For hepatic impairment participants with overt ascites, the BMI was to be within the range of 18 to 45 kg/m
- •Ability to communicate well with the Investigator, to understand and comply with the requirements of the study.
- •Participant was willing to remain in the clinical research unit as required by the protocol
排除标准
- •Participants meeting any of the following criteria were excluded from this study:
- •Use of other investigational drugs within the last 30 days or 5 half-lives prior to dosing, whichever was longer.
- •History of hypersensitivity to the investigational compound/compound class or its excipients being used in this study.
- •Pregnant or nursing (lactating) women. Pregnancy was defined as the state of a female after conception and until termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
- •Known history of, or current clinically significant arrhythmias, history of prolonged QT correction formula (QTcF) interval or QTcF > 450 msec (males) or QTcF > 460 msec (females) at screening in healthy participants and history of prolonged QTcF interval or QTcF > 470 msec (males) or QTcF > 480 msec (females) at screening in participants with hepatic impairment.
研究组 & 干预措施
Healthy participants
Iptacopan 200 mg single dose
干预措施: Iptacopan (Drug)
Mild hepatic impairment patients
Iptacopan 200 mg single dose
干预措施: Iptacopan (Drug)
Moderate hepatic impairment patients
Iptacopan 200 mg single dose
干预措施: Iptacopan (Drug)
Severe hepatic impairment patients
Iptacopan 200 mg single dose
干预措施: Iptacopan (Drug)
结局指标
主要结局
Pharmacokinetic parameters of iptacopan: Cmax The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass × volume-1)
时间窗: Day 1 (few time points), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 and Day 11
To assess the PK properties of iptacopan after a single oral dose of 200 mg in participants with mild, moderate, or severe hepatic impairment as compared to matched healthy participants with normal hepatic function (Child-Pugh classification).
Pharmacokinetics parameters of iptacopan: AUCinf The AUC from time zero to infinity (mass × time × volume-1)
时间窗: Day 1 (few time points), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 and Day 11
to assess the PK properties of iptacopan after a single oral dose of 200 mg in participants with mild, moderate, or severe hepatic impairment as compared to matched healthy participants with normal hepatic function (Child-Pugh classification).
Pharmacokinetics parameters of iptacopan: Tmax The time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time)
时间窗: Day 1 (few time pints), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 and Day 11
To assess the PK properties of iptacopan after a single oral dose of 200 mg in participants with mild, moderate, or severe hepatic impairment as compared to matched healthy participants with normal hepatic function (Child-Pugh classification).
Pharmacokinetic parameters of iptacopan: AUClast The AUC from time zero to the last measurable concentration sampling time (tlast) (mass × time × volume-1)
时间窗: Day 1 (few time points), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 and Day 11
To assess the PK properties of iptacopan after a single oral dose of 200 mg in participants with mild, moderate, or severe hepatic impairment as compared to matched healthy participants with normal hepatic function (Child-Pugh classification).
次要结局
未报告次要终点